Tinaazole Capsule 150 mg (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Oral formulations are absorbed rapidly and almost completely; therefore, the doses of oral formulations (tablets, capsules, dry syrup) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer a single oral dose of 150 mg as fluconazole. 2. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this drug is 400 mg once on the first day, followed by 200 mg once daily from the next day. The dose may be increased to 400 mg once daily according to the patient's response. The duration of treatment should be determined according to clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this drug is 400 mg once on the first day, followed by 200-400 mg once daily from the next day. The duration of treatment depends on the clinical and mycological response, but treatment should usually continue for at least 6 ~ 8 weeks. 4. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this drug once daily indefinitely after the patient has completed primary treatment. 5. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation: Administer 50-400 mg of this drug once daily according to the patient's risk of fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infection, such as bone marrow transplant recipients with severe neutropenia or an anticipated prolonged period of neutropenia. In these patients, administer 400 mg starting 5-6 days before the anticipated onset of neutropenia, and continue 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. 6. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). New fingernails generally take 3-6 months to grow, and toenails take about 6-12 months; growth rates may vary by individual and age. Occasionally, nails may remain damaged after successful treatment with long-term administration. Dermatophyte infections, including tinea pedis (athlete's foot), tinea corporis, tinea cruris (jock itch), and cutaneous candidiasis: The usual dose of this drug is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, tinea pedis may require treatment for 6 weeks depending on the course. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, the usual adult dose is administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. ○ Patients with renal impairment This drug is excreted primarily in the urine unchanged. No dose adjustment is necessary for a single dose. If multiple doses are required, administer the usual dose only on the first day of treatment and adjust the dose from the next day as follows: Creatinine clearance (mL/min) > 50: 100 % of the usual dose Creatinine clearance (mL/min) ≤50 (not on dialysis): 50% of the usual dose Patients on hemodialysis: 100% of the usual dose after each hemodialysis session Patients receiving hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days when dialysis is not performed, administer a reduced dose according to creatinine clearance.

This medication is an azole antifungal and should not be used in certain patients. In particular, individuals allergic to this medication or similar drugs, pregnant women or women of childbearing potential, and nursing mothers should not take this medication. Additionally, serious side effects may occur when taken with certain drugs, so individuals currently taking medication must consult with healthcare professionals. This medication contains lactose, so patients with lactose intolerance or hereditary metabolic disorders should exercise caution. Patients with impaired kidney or liver function, heart disease, or electrolyte abnormalities should use this medication more cautiously as it can affect heart rhythm, necessitating careful monitoring of heart status. Furthermore, this medication affects the metabolism of various drugs, so adjustment or monitoring of the types and dosages of concurrently taken medications may be necessary. While this medication is generally well tolerated, it can rarely affect the blood, liver, and kidneys, with adverse reactions such as rashes, headaches, digestive disorders, and cardiac arrhythmias. Particularly in severely ill patients, the risk of severe liver function impairment increases, making regular liver function tests important. Taking this medication during pregnancy may pose a risk of congenital malformations or spontaneous abortion to the fetus, so it should be avoided during pregnancy, and women of childbearing age should implement effective contraception during and for one month after treatment. Nursing mothers are also advised against using this medication as it is excreted in breast milk. The safety in children, especially infants under 6 months old, has not been sufficiently established, and it should be used cautiously only when necessary. During treatment with this medication, dizziness or seizures might occasionally occur, so caution is advised when driving or operating machinery. In case of an overdose, hallucinations or abnormal behavior may occur, requiring immediate medical treatment. This medication is primarily excreted through urine, so in case of overdose, increasing urine output or removing the drug via hemodialysis may be necessary.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, lightheadedness, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, distension, dry mouth, increased ALT, increased AST, elevated serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocellular necrosis, hepatitis, hepatocellular damage, rash, pruritus, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, alopecia, drug reactions with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, asthenia, fever, adrenal insufficiency, hallucinations, altered behavior

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Capsule filled with white powder; the upper part is dark blue and the lower part is light blue.

Package unit

10 capsules [(10 capsules/PTP) × 1], 30 capsules/bottle, 100 capsules/bottle, 300 capsules/bottle